Sanuwave (OTC:SNWV) (Alpharetta,Ga.) will begin the process of submitting its data to the FDA for approval of its dermaPace device for treating diabetic foot ulcers (DFU) and it will not make any changes to the clinical trial evaluating the device after it had a "positive" meeting with the agency earlier this month, the company said during a call on Tuesday.
After reviewing a handful of studies published since 2013 the American Heart Association/American Stroke Association (Dallas) has issued new guidelines for treating patients with clot-caused (ischemic) stroke. For the first time, the organization is recommending the use of a stent retrieval device to remove blood clots in select stroke patients who have clots obstructing the large arteries supplying blood to the brain. The new guidelines are published in the AHA journal Stroke.